PRINCIPAL CONSULTANT - LIFESCIENCES

Key Responsibilities:

• 14 years of experience in Life Sciences with CSV Validation for GxP systems
• Serve as a subject matter expert for Quality Engineering practice on IT systems and solutions including
• Clinical Trial Management Systems CTMS Veeva CTMS Medidata Rave Oracle Siebel
• Regulatory Platforms Veeva Vault RIM Veeva Vault
• Laboratory Information Management Systems LIMS LabVantage LabWare STAR LIMS
• Supply Chain Kinaxis
• Knowledge of key Pharma regulations including 21 CFR Part 11 EU Annex 11 CSA 21 CFR Part 820 GAMP5 principles
• Know how of compliance with FDA EMA ICH and other regulatory frameworks for Life Sciences
• Participate in business development activities including proposals solution demos and client workshops
• Must have experience using Test management tools like ALM qTest JiRA
• Strong hands on experience in CSV CSA deliverables lifecycle including
• a
• Validation Plan
• b
• URS FRS analysis
• c
• Risk assessment
• d
• Val IQ OQ PQ test cases creation updates execution
• Familiarity with Valgenesis or Kneat is nice to have
• Familiarity with cloud technologies AWS Azure data standards GDPR HL7 and cybersecurity in regulated environments
• Strong communication interpersonal skills
• Ability to work independently and with cross functional teams is preferred

Technical Requirements:

• PROJECT MANAGEMENT LIMS Testing GxP Testing

Preferred Skills:

Domain->LifeSciences->LifeSciences - ALL,Foundational->Project Management->Project Management,Technology->Life Sciences->LIMS